Medical policy determinations for pharmacogenetic tests among US health plans.

Objectives: To evaluate medical policy determinations for pharmacogenetic (PGx) testing for 65 clinically relevant drug-gene pairs and evidence cited to support determinations across major US health plans and laboratory benefit managers (LBMs).

Study design: Landscape analysis of available PGx medical policies to determine coverage status of certain drug-gene pairs.

Methods: PGx medical policies as of February 1, 2024, were ascertained through Policy Reporter for top national insurers, LBMs, and the Palmetto GBA Molecular Diagnostic Services (MolDX) Program, which determines whether a molecular diagnostic test is covered by Medicare. Data elements included date of last policy update, coverage status for each drug-gene pair, and evidence cited for or against coverage. A drug-gene pair was considered covered if the policy indicated that a PGx test was deemed medically necessary and/or meets coverage criteria.

Results: Policies from 8 insurers, 3 LBMs, and MolDX were available and reviewed. MolDX covered all 65 individual drug-gene pairs, followed by Avalon Healthcare Solutions (n = 50) and UnitedHealthcare (n = 45); these 3 also covered multigene panels. Eight policies covered 10 or fewer drug-gene pairs. HLA-B*57:01 testing prior to abacavir initiation and HLA-B*15:02 testing prior to carbamazepine initiation were covered across all policies. Drug-gene pairs with Clinical Pharmacogenetics Implementation Consortium guidelines and/or included in the FDA's Table of Pharmacogenetic Associations Section 1 were more commonly covered. Society guidelines were the most frequently cited evidence (413 times), and cost-effectiveness studies were infrequently cited (43 times).

Conclusions: We found significant variability in medical policy determinations and evidence cited for clinically relevant PGx tests among major US health insurers and LBMs. A collaborative effort between payers and the PGx community to standardize evidence evaluation may lead to more consistent coverage and improve patient access to PGx tests meeting evidence requirements.